Trial Outcomes & Findings for Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI (NCT NCT03943160)

Last Updated: 2023-07-18

Results Overview

Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)

Results posted on

2023-07-18

Participant Flow

Following physician assessment of patient and general inclusion/exclusion and informed consent signature, subjects were eligible for enrollment pending index procedure inclusion and exclusion criteria.

Participant milestones

Participant milestones
Measure	OAS Use Via Transradial Access (TRA) All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OAS Use Via Transradial Access (TRA) n=50 Participants All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
Age, Continuous	70.9 Years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=5 Participants
Race/Ethnicity, Customized White	33 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants
Baseline Rutherford Clinical Category Moderate Claudication (2)	6 Participants n=5 Participants
Baseline Rutherford Clinical Category Severe Claudication (3)	31 Participants n=5 Participants
Baseline Rutherford Clinical Category Ischemic Rest Pain (4)	12 Participants n=5 Participants
Baseline Rutherford Clinical Category Minor Tissue Loss (5)	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)

Outcome measures

Outcome measures
Measure	OAS Use Via Transradial Access (TRA) n=50 Participants All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
Procedural Success:	49 Participants

SECONDARY outcome

Timeframe: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

Treatment success is defined as \<50% residual stenosis post-procedure and without significant angiographic complications without stent placement, or \<30% residual stenosis post-procedure and without significant angiographic complications with stent placement.

Outcome measures

Outcome measures
Measure	OAS Use Via Transradial Access (TRA) n=50 Participants All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
Treatment Success:	49 Participants

Adverse Events

OAS Use Via Transradial Access (TRA)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OAS Use Via Transradial Access (TRA) n=50 participants at risk All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
Vascular disorders Lower Extremity Disorders	2.0% 1/50 • Number of events 1 • The reporting of adverse events (AEs) began immediately after the subject was enrolled through the first standard of care follow-up visit (7 - 45 days post-procedure). For the purposes of this study, pre-planned interventions noted at baseline were not considered reportable AEs. Adverse events were limited to: SAEs, TRA Related Events, Significant Angiographic Events and OAS and ViperCath device related serious injuries. The reporting of AEs began immediately after the subject was enrolled through study exit.
Injury, poisoning and procedural complications Procedural Complications, Lower Extremities	2.0% 1/50 • Number of events 1 • The reporting of adverse events (AEs) began immediately after the subject was enrolled through the first standard of care follow-up visit (7 - 45 days post-procedure). For the purposes of this study, pre-planned interventions noted at baseline were not considered reportable AEs. Adverse events were limited to: SAEs, TRA Related Events, Significant Angiographic Events and OAS and ViperCath device related serious injuries. The reporting of AEs began immediately after the subject was enrolled through study exit.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trials Manager

Cardiovascular Systems Inc.

Phone: 651.259.2500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60